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Appendix A: Glossary
Pages 105-108

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From page 105...
... Confidentiality commitment: A document that sets up the legal framework for a regulatory authority to share certain kinds of nonpublic information with regulatory counterparts in foreign countries and international organizations as part of cooperative law enforcement or regulatory activities. Conformity assessment: A systematic examination to determine the extent to which a product, process, or service fulfills specified requirements.
From page 106...
... Good manufacturing practice (GMP) : The part of quality management that ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization, or product specification.
From page 107...
... Regulatory framework: The collection of laws, regulations, guidelines, and other regulatory instruments through which a government controls the manufacture, clinical evaluation, marketing, promotion, and post-­ marketing safety benchmarking of medical products. Regulatory system: The system composed of entities responsible for the registration, marketing authorization, and other regulatory functions concerning medical products.
From page 108...
... Work sharing: The act whereby two or more medicines regulatory agencies agree to work together on a specific regulatory activity. Such work sharing may be on a reactive ad hoc basis or an established proactive routine basis.


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